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

Model Number	G50326
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Name and address: postal code: (b)(6).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 an unknown procedure a advance 14 lp low profile balloon catheter ruptured during inflation.The device was advanced through the femoral artery ipsilaterally with another manufacturer's sheath to treat a 90% occluded lesion below the knee.The device was inflated to 8 atm with an indeflator for about 10 seconds.Another manufacturer's device was used to complete the procedure.No adverse effects to the patient were reported.
Additional Manufacturer Narrative
Event summary: as reported, during an unknown procedure a advance 14 lp low profile balloon catheter ruptured during inflation.The device was advanced through the femoral artery ipsilaterally with another manufacturer's sheath to treat a 90% occluded lesion below the knee.The patient's anatomy was calcified.The device was inflated to 8 atm with an inflator for about 10 seconds.Another manufacturer's device was used to complete the procedure.No adverse effects to the patient were reported.Investigation - evaluation: a document-based investigation was performed including a review of complaint history, device history record, drawing, specifications, quality control data, and the instructions for use (ifu).The complaint device was not returned; therefore, no physical examinations could be performed.Cook reviewed the dhr.The dhr for complaint final complaint device lot revealed no nonconformances.The balloon catheter subassembly is used in the complaint final lot and the subassembly records relevant nonconformances for failed leakage tests, and all nonconforming product was scrapped and the lot is inspected 100%.The balloon raw material lots were used in the subassembly lot of the complaint device and in 3 additional subassembly lots.These lots record relevant nonconformances for failed leakage tests, and all nonconforming product was scrapped and the lots are inspected 100%.The lot was also used final lots.All of these final lots recorded no nonconformances.A database search for all lots related to and including the complaint lot found no related complaints.Although these non-conformances are relevant to the reported failure mode, all non-conforming product was scrapped, there are 100% inspections to capture this non-conformance.Adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that non-conforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings: ¿do not exceed rated burst pressure.Rupture of balloon may occur.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.¿ ¿do not use a power injector for balloon inflation.Rupture may occur.¿ precautions: ¿in heavily scarred access sites, use of an introducer sheath is recommended.¿ ¿manipulate the catheter using fluoroscopic control.¿ instructions for use: balloon preparation: ¿1.Choose a balloon appropriate to lesion length and vessel diameter.¿ ¿2.Upon removal from package, inspect catheter to ensure no damage has occurred during shipping.¿ balloon introduction and inflation: ¿5.Inflate the balloon to desired pressure.Adhere to recommended balloon inflation pressures.(see compliance card insert.) ¿6.If balloon pressure is lost and / or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.¿ balloon deflation and withdrawal: ¿3.If resistance is encountered during withdrawal, apply negative pressure with a larger syringe before proceeding.If resistance continues, remove balloon and sheath as a unit.¿ how supplied: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ the customer stated that the patient¿s vessels were calcified and approximately 90% occluded.Therefore, cook concluded that patient anatomy was the primary contributing factor in the reported incident.Additionally, the information provided upon review of complaint file, device history record, complaint history, device master record, and design verification testing provide objective evidence to support that the device was manufactured to specification.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No new patient or event information to report since the previous medwatch report was submitted.
Event or Problem Description
Information was inadvertently omitted from the previous report.The patient's anatomy was calcified.
Additional Manufacturer Narrative
Corrected information: the following information was available and inadvertently omitted from the initial report: b5, d10.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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: 12268711
• Report Number: 1820334-2021-01912
• Device Sequence Number: 4317784
• Product Code: LIT
• UDI-Device Identifier: 10827002503264
• UDI-Public: (01)10827002503264(17)211029(10)9266951
• Combination Product (Y/N): N
• PMA/510(K) Number: K170193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2021

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 Expiration Date: 10/29/2021
• Device Model Number: G50326
• Device Catalogue Number: PTAX4-14-170-2.5-20
• Device Lot Number: 9266951
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 07/16/2021; 10/08/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 10/06/2021; 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO 4FR SHORT SHEATH