MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. BANTAM ALPHA OTW PTA CATHETER; PTA BALLOON DILATATION CATHETER

Catalog Number 50125220

Device Problems Break (1069); Stretched (1601); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2022

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the sleek otw pta dilatation catheter that are cleared in the us.The pro code and 510 k number for the sleek otw pta dilatation catheter are identified.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 02/2023).

Event Description

It was reported that during preparation for an angioplasty procedure, the shaft was allegedly damaged.It was further reported that the balloon was disconnected from rest of the catheter.The procedure was completed by using another device.There was no patient contact.

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the sleek otw pta dilatation catheter that are cleared in the us.The pro code and 510 k number for the sleek otw pta dilatation catheter are identified.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 02/2023).

Event Description

It was reported that during preparation for an angioplasty procedure, the shaft was allegedly damaged.It was further reported that the balloon was disconnected from rest of the catheter.The procedure was completed by using another device.There was no patient contact.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the sleek otw pta dilatation catheter that are cleared in the us.The pro code and 510 k number for the sleek otw pta dilatation catheter are identified in d2 and g4.H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.However, the device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for these reports.Investigation summary: the sample was not returned for evaluation.The result of the investigation is confirmed for the reported catheter break issue.The review of an image provided confirmed the lower distal section of the catheter comprising of the balloon and distal tip appeared separate to the rest of the catheter.The catheter break was likely related to user handling techniques due to excessive force been responsible occurring during the attempted sleeve removal during device preparation.The root cause for the reported catheter break issue could not be determined based upon the available information received from the field communications an image review.Labeling review: the instructions for use for the bantam alpha catheter was reviewed and contains the following information relevant to the reported event: warnings: ¿ visually inspect the packaging to verify that the sterile barrier is intact.Do not use if the sterile barrier is opened or damaged.Precautions: ¿ carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.¿ proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Do not continue to use the balloon catheter if the shaft has been bent or kinked.Directions for use: inspection and preparation ¿ remove the protective sheath by first withdrawing the stylet and then slowly removing the sheath while holding the catheter as close to the balloon as possible.¿ if any resistance is felt, or if any stretching of the catheter is observed while removing the protective sheath, the product should not be used.¿ the catheter should then be inspected for bends, kinks or stretched portions.Do not use if product damage is evident.¿ reinserting the balloon into the protective sheath may damage the balloon or catheter.H10: d4 (expiry date: 02/2023), device not returned.

Event Description

It was reported that during preparation for an angioplasty procedure, the shaft was allegedly damaged.It was further reported that the balloon was disconnected from rest of the catheter.The procedure was completed by using another device.There was no patient contact.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the sleek otw pta dilatation catheter that are cleared in the us.The pro code and 510 k number for the sleek otw pta dilatation catheter are identified in d2 and g4.H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.However, the device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for these reports.Investigation summary: the bantam device was returned in 3 sections.The first section comprised of the hub and the outer, the second section was the inner which was stretched, the third section comprised of the balloon and distal tip.A detachment of section 1 and 3 at the proximal bond (balloon and distal tip section was detached from the outer) was confirmed.The result of the investigation is confirmed for the reported catheter damage and the balloon detachment from the catheter.The catheter damage detached balloon section from the catheter and stretched inner point user applying excessive force during the attempted sleeve removal from the balloon during device preparation.The root cause for the reported catheter damage and balloon detachment issues could not be fully determined based upon the available information received from the field communications, device evaluation and image review.Labeling review: the instructions for use for the bantam alpha catheter was reviewed and contains the following information relevant to the reported event: warnings: ¿ visually inspect the packaging to verify that the sterile barrier is intact.Do not use if the sterile barrier is opened or damaged.Precautions: ¿ carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.¿ proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Do not continue to use the balloon catheter if the shaft has been bent or kinked.Directions for use: inspection and preparation ¿ remove the protective sheath by first withdrawing the stylet and then slowly removing the sheath while holding the catheter as close to the balloon as possible.¿ if any resistance is felt, or if any stretching of the catheter is observed while removing the protective sheath, the product should not be used.¿ the catheter should then be inspected for bends, kinks or stretched portions.Do not use if product damage is evident.¿ reinserting the balloon into the protective sheath may damage the balloon or catheter.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that during preparation for an angioplasty procedure, the shaft was allegedly damaged.It was further reported that the balloon was disconnected from rest of the catheter.The procedure was completed by using another device.There was no patient contact.

• Brand Name: BANTAM ALPHA OTW PTA CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13512466
• MDR Text Key: 286333412
• Report Number: 9616666-2022-00011
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 05391515545168
• UDI-Public: (01)05391515545168
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K130786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50125220
• Device Lot Number: CMEQ0451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male