MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	G30946
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name and address - (b)(6).Customer (person) - mobile phone: (b)(6).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.
Event or Problem Description
As reported, during a percutaneous transluminal angioplasty procedure of the infrainguinal posterior tibial artery, an advance 18 lp low profile balloon catheter ruptured.Another manufacturer's 6 fr sheath and inflation device were used during the procedure.Omnipaque 50/50 contrast was used and the patient's anatomy was not angulated, tortuous, or calcified.Upon the first inflation of the balloon to 8 atmospheres in the 50% occluded lesion within the posterior tibial artery, the balloon ruptured circumferentially.The balloon was removed by itself, over another manufacturer's wire, without counterclockwise rotation.Blood was not noted in the inflation device and the balloon was not inflated inside of a stent prior to the rupture.Negative pressure was not maintained after rupture.Another manufacturer's device was used to continue the procedure.A section of the device did not remain inside the patient's body.Additional information has been requested.
Event or Problem Description
Additional information was received on 13mar2023 and 16mar2023.The patient did not require any additional procedures due to this event.Another manufacturer's same-size balloon was used to successfully complete the procedure.
Additional Manufacturer Narrative
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 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.
Additional Manufacturer Narrative
Summary of event: as reported, during a percutaneous transluminal angioplasty procedure of the infrainguinal posterior tibial artery, an advance 18 lp low profile balloon catheter ruptured.Another manufacturer's 6 fr sheath and inflation device were used during the procedure.Omnipaque 50/50 contrast was used, and the patient's anatomy was not angulated, tortuous, or calcified.Upon the first inflation of the balloon to 8 atmospheres in the 50% occluded lesion within the posterior tibial artery, the balloon ruptured circumferentially.The balloon was removed by itself, over another manufacturer's wire, without counterclockwise rotation.Blood was not noted in the inflation device and the balloon was not inflated inside of a stent prior to the rupture.Negative pressure was not maintained after rupture.Another manufacturer's device was used to continue the procedure.A section of the device did not remain inside the patient's body.Additional information was received 13mar2023 and 16mar2023.The patient did not require any additional procedures due to this event.Another manufacturer's same-size balloon was used to successfully complete the procedure.Investigation evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The product ifu states ¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.¿ the information provided upon review of the dmr, dhr, and ifu suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a component failure contributed to this event.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ADVANCE 18 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 16521265
• Report Number: 1820334-2023-00243
• Device Sequence Number: 15096398
• Product Code: LIT
• UDI-Device Identifier: 10827002309460
• UDI-Public: (01)10827002309460(17)250520(10)14743041
• Combination Product (Y/N): N
• PMA/510(K) Number: K130293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2023

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: 05/20/2025
• Device Model Number: G30946
• Device Catalogue Number: PTA4-18-150-3-20
• Device Lot Number: 14743041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 03/13/2023; 06/27/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/07/2023; 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 0.018 COMMAND WIRE; 0.035 TERUMO WIRE; 6 FR MERIT SHEATH; SUNMED INFLATION DEVICE; TRAILBLAZER 0.018
• Patient Age: 66 YR
• Patient Sex: Male