MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. SLEEK RX PTA CATHETER; PTA BALLOON DILATATION CATHETER

Catalog Number	425-2512X
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 03/2026).H11: section a through f ¿ the information provided by bd represents all 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 or Problem Description
It was reported that prior to a percutaneous transluminal angioplasty procedure, a hair was allegedly found in the sterile packaging of the balloon catheter.There was no patient contact.
Additional Manufacturer Narrative
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 this event.Investigation summary: the device was returned for evaluation.The device was returned within its hoop and pouch.The pouch had been previously opened, it was sealed with staples on two sides.A strand of hair was located beneath the device hoop.The hair measured >20mm in length.Also, one image was also provided for review.The image provided showed a section of the device pouch packaging, been held by a healthcare personnel.The hooped catheter was visible within the pouch.The healthcare personnel was shown pointing to a hair that appears to be within the pouch in contact with the hoop.There is no indication that the pouch has been opened.Therefore, the result of the investigation is confirmed for the reported pouch contamination issue.The root cause for the reported pouch contamination issue could not be fully determined based upon the available information received from the field communications, device evaluation and image review.However, escapes from visual inspection at the manufacturing packing step may have contributed to this reported issue.Labeling review: the instructions for use for this sleek rx device was reviewed and the following sections are applicable.Indications: the sleek® catheters are intended for balloon dilatation of the femoral, popliteal and infra-popliteal arteries.These catheters are not designed to be used in the coronary arteries.Contraindications: none known.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 the 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.Directions for use: inspection and preparation: remove the balloon sleeve by first withdrawing the shipping mandrel slightly and then slowly removing the sleeve 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 balloon sleeve, 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.H10: d4 (expiration date: 03/2026).H11: h6 (method).H11: section a through f ¿ the information provided by bd represents all 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 or Problem Description
It was reported that prior to a percutaneous transluminal angioplasty procedure, a hair was allegedly found in the sterile packaging of the balloon catheter.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.However, one image was provided for review.The image showed a section of the device pouch packaging, been held by a health care provider.The hooped catheter was visible within the pouch.The health care provider was shown pointing to a hair that appears to be within the pouch in contact with the hoop.There is no indication that the pouch has been opened.Therefore, the result of the investigation is confirmed for the reported pouch contamination issue.The root cause for the reported pouch contamination issue could not be fully determined based upon the available information received from the field communications and image review.Labeling review: the instructions for use for this sleek rx device was reviewed and the following sections are applicable.Indications: ¿ the sleek® catheters are intended for balloon dilatation of the femoral, popliteal and infra-popliteal arteries.These catheters are not designed to be used in the coronary arteries.Contraindications: ¿ none known.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 the 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.Directions for use: inspection and preparation: ¿ remove the balloon sleeve by first withdrawing the shipping mandrel slightly and then slowly removing the sleeve 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 balloon sleeve, 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.H10: d4 (expiration date: 03/2026).H11: section a through f ¿ the information provided by bd represents all 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.H3 other text : device not returned.
Event or Problem Description
It was reported that prior to a percutaneous transluminal angioplasty procedure, a hair was allegedly found in the sterile packaging of the balloon catheter.There was no patient contact.

• Brand Name: SLEEK RX PTA CATHETER
• Common Device Name: 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: 18473179
• Report Number: 9616666-2023-00272
• Device Sequence Number: 12498634
• Product Code: LIT
• UDI-Device Identifier: 00801741132377
• UDI-Public: (01)00801741132377
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K072947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 425-2512X
• Device Lot Number: CMHR0325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 02/08/2024; 04/26/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 02/16/2024; 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown