MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	G50324
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Pma/510(k) number = k170193.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during angioplasty of the superficial femoral artery in the "infrapopliteal sector", an advance 14 lp low profile balloon catheter "punctured" upon the first inflation of the device.An unknown 5 french sheath and unknown guide wire were used during the procedure.The anatomy was not reported to be tortuous or calcified.An unspecified inflation device was used to inflate the balloon to nominal pressure using an unknown solution.At the time of puncture, blood was noted in the inflation device.The balloon was not inflated within a stent.The balloon and sheath were removed together, with the wire guide in place.It is unknown if the balloon was allowed to return to ambient pressure; however, negative pressure was not maintained during removal and a counterclockwise rotation of the balloon was not conducted.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, during angioplasty of the superficial femoral artery in the "infrapopliteal sector", an advance 14 lp low profile balloon catheter "punctured" upon the first inflation of the device.An unknown 5 french sheath and unknown guide wire were used during the procedure.The anatomy was not reported to be tortuous or calcified.An unspecified inflation device was used to inflate the balloon to nominal pressure using an unknown solution.At the time of puncture, blood was noted in the inflation device.The balloon was not inflated within a stent.The balloon and sheath were removed together, with the wire guide in place.It is unknown if the balloon was allowed to return to ambient pressure; however, negative pressure was not maintained during removal and a counterclockwise rotation of the balloon was not conducted.Investigation - evaluation.Reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, and quality control procedures, and a visual inspection and functional of the device were conducted during the investigation.One ptax balloon was returned in a used state, with biomatter present.No damage was visually observed to the catheter or balloon.The balloon was inflated with water, and a pinhole leak was found near the proximal bond.A review of the device history record revealed no nonconformances which could have contributed to the device failure.A review of complaints showed no other complaints associated with the product lot.Reviews of the manufacturing instructions, drawing, and quality control procedures were also conducted, and no gaps were discovered.The information reviewed provides evidence to support that the device and items in the lot were manufactured to specification.The device is packaged with instructions for use, which state, ¿do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.Over-inflation may cause rupture of the balloon, which resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.¿ based on the information provided and inspection of the returned device, investigation has concluded that a cause for the device failure could not be established, though it is possible that the patient¿s reportedly calcified anatomy may have contributed to the event.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9659578
• Report Number: 1820334-2020-00263
• Device Sequence Number: 3475277
• Product Code: LIT
• UDI-Device Identifier: 10827002503240
• UDI-Public: (01)10827002503240(17)220411(10)9662535
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

1 Device 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 Expiration Date: 04/11/2022
• Device Model Number: G50324
• Device Catalogue Number: PTAX4-14-170-2.5-12
• Device Lot Number: 9662535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No