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

Model Number	425-2504X
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
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 return of the sample is pending.The investigation of the reported event is currently underway.(expiration date: 11/2021).
Event or Problem Description
It was reported that during an angioplasty procedure in left posterior tibial artery, the pta balloon allegedly ruptured on second inflation at 10 atm.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: the sample was not returned for evaluation.The result of the investigation is inconclusive for the reported balloon rupture issue.The root cause for the reported balloon rupture issue could not be determined based upon the available information received from the field communications.Labeling review: instructions for use for sleek pta rapid exchange (rx) dilatation catheter product family was reviewed the following sections are applicable: balloon characteristics: please check the package label for the rated burst pressure (rbp).It is important that the balloon not be inflated beyond the rated burst pressure.Pressures in excess of rated burst pressure may cause the balloon to burst.Compliance charts are provided with each product.The semi-compliant balloon has a 8% ± 4% growth in diameter from nominal to rated burst pressure.All inflations should be viewed under fluoroscopy.The sleek® balloons reach their nominal diameter at 6 atm (608 kpa).Warnings: do not exceed the rated burst pressure.A syringe with pressure gauge is recommended to monitor pressure.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Use only an endoflator or 20 ml syringe for inflation.Do not exceed the following rated burst pressures: 16 atm/1621 kpa (40 - 60 mm).15 atm /1520 kpa (80 - 220 mm).Precautions: if resistance is felt upon removal, then the balloon, guidewire and the sheath/ guide catheter should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.This may be accomplished by firmly grasping the balloon catheter and sheath/guide catheter as a unit and withdrawing both together, using a gently twisting motion combined with traction.Before removing catheter from sheath/guide catheter it is very important that the balloon is completely deflated.H10: d4 (expiry date: 11/2021), g3, h6 (method).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.H3 other text : device not returned.
Event or Problem Description
It was reported that during an angioplasty procedure in left posterior tibial artery, the pta balloon allegedly ruptured on second inflation at 10 atm.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: the sample was returned for evaluation.The visual evaluation of the returned device did not observe a rupture in the balloon.There was evidence that the balloon has been expanded.The result of the investigation is inconclusive for the reported balloon rupture issue.Due to the condition of the returned device a functional examination could not be performed.The outer was detached from the balloon at the proximal bond.A detachment was confirmed on the device.The root cause for the reported balloon rupture issue could not be determined based upon the available information received from the field communications and device evaluation.Labeling review: instructions for use for sleek pta rapid exchange (rx) dilatation catheter product family was reviewed the following sections are applicable: balloon characteristics: please check the package label for the rated burst pressure (rbp).It is important that the balloon not be inflated beyond the rated burst pressure.Pressures in excess of rated burst pressure may cause the balloon to burst.Compliance charts are provided with each product.The semi-compliant balloon has a 8% ± 4% growth in diameter from nominal to rated burst pressure.All inflations should be viewed under fluoroscopy.The sleek balloons reach their nominal diameter at 6 atm (608 kpa).Warnings: do not exceed the rated burst pressure.A syringe with pressure gauge is recommended to monitor pressure.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Use only an endoflator or 20 ml syringe for inflation.Do not exceed the following rated burst pressures: 16 atm/1621 kpa (40 - 60 mm) 15 atm /1520 kpa (80 - 220 mm) precautions: if resistance is felt upon removal, then the balloon, guidewire and the sheath/ guide catheter should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.This may be accomplished by firmly grasping the balloon catheter and sheath/guide catheter as a unit and withdrawing both together, using a gently twisting motion combined with traction.Before removing catheter from sheath/guide catheter it is very important that the balloon is completely deflated.H10: d4 (expiry date: 11/2021), g3, h6 (device) h11: h6 (method, result) 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.H3 other text : see h10.
Event or Problem Description
It was reported that during an angioplasty procedure in left posterior tibial artery, the pta balloon allegedly ruptured on second inflation at 10 atm.There was no reported patient injury.

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13203010
• Report Number: 9616666-2021-00252
• Device Sequence Number: 4404952
• Product Code: LIT
• UDI-Device Identifier: 00801741132308
• UDI-Public: (01)00801741132308
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K072947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2022

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 Model Number: 425-2504X
• Device Catalogue Number: 425-2504X
• Device Lot Number: CMCZ0276
• 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: 12/13/2021
• Supplement Date Received by Manufacturer: 01/31/2022; 04/05/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 02/02/2022; 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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