MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	G52300
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during a procedure involving stent placement, an advance 35 lp low profile balloon catheter ruptured and subsequently separated.After stent implantation, an unspecified pressure pump was used to inflate the balloon one time, within a 30% occluded lesion in the iliac vein; however, the balloon ruptured longitudinally at six atmospheres.The anatomy was not tortuous, calcified, or scarred.The balloon was not inflated within a stent, and blood was not noted in the inflation device.The user attempted to remove the ruptured balloon and catheter from another manufacturer's 9-french sheath and also attempted to remove the balloon and sheath as a unit; however, the device could not be removed despite multiple attempts.Negative pressure was not maintained, nor was a counter-clockwise rotation conducted during attempted removal of the device.A cut-down of the popliteal vein was performed and the balloon was removed.The procedure was completed.A photo provided by the customer appears to show rupture and separation of the balloon and balloon catheter.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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.
Event or Problem Description
Upon return and initial evaluation of the device, the balloon material was separated and the catheter shaft was elongated/stretched.The catheter shaft was not separated as previously reported.
Additional Manufacturer Narrative
Summary of event: as reported, during a procedure involving stent placement, an advance 35 lp low profile balloon catheter ruptured and subsequently separated.After stent implantation, an unspecified pressure pump was used to inflate the balloon one time, within a 30% occluded lesion in the iliac vein; however, the balloon ruptured longitudinally at six atmospheres.The anatomy was not tortuous, calcified, or scarred.The balloon was not inflated within a stent, and blood was not noted in the inflation device.The user attempted to remove the ruptured balloon and catheter from another manufacturer's 9-french sheath and also attempted to remove the balloon and sheath as a unit; however, the device could not be removed despite multiple attempts.Negative pressure was not maintained, nor was a counter-clockwise rotation conducted during attempted removal of the device.A cut-down of the popliteal vein was performed and the balloon was removed.The procedure was completed.A photo provided by the customer appears to show rupture and separation of the balloon and balloon catheter.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Upon return and initial evaluation of the device, the balloon material was separated, and the catheter shaft was elongated/stretched.The catheter shaft was not separated.Investigation evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), specifications, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation, along with a competitor's device.The balloon was in several pieces, and the shaft was elongated and lodged inside the competitors¿ device.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 that the device is intended for use in the peripheral arteries and within arteriovenous fistulae.The ifu instructs ¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.¿ the ifu warns ¿if resistance is met during withdrawal, apply negative pressure with a larger syringe before proceeding.If resistance continues, remove balloon and sheath as a unit.¿ the ifu also states ¿upon catheter withdrawal, a gentle counterclockwise rotation of the catheter will assist balloon rewrap, minimizing trauma to the percutaneous entry site.¿ the information provided upon review of the dmr, dhr, ifu, and investigation of the returned device 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 procedural/user issues contributed to this incident.Per the ifu, the device is intended for use in the peripheral arteries; however, in this case, the device was inflated within a 30% occluded lesion in the iliac vein.Resistance was encountered upon withdrawal; however, negative pressure was not maintained and a counterclockwise rotation of the catheter was not performed, as instructed in the ifu.The risk analysis for this failure mode was reviewed and no additional escalation is 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 35 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• 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: 16246522
• Report Number: 1820334-2023-00071
• Device Sequence Number: 20484357
• Product Code: DQY
• UDI-Device Identifier: 10827002523002
• UDI-Public: (01)10827002523002(17)250401(10)CINC001178
• Combination Product (Y/N): N
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2025
• Device Model Number: G52300
• Device Catalogue Number: PTA5-35-135-12-8.0
• Device Lot Number: CINC001178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 01/27/2023; 04/20/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 02/14/2023; 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON TIPS STENTS AND IV STENTS/DELIVERY SYSTEM; TERUMO 9 FRENCH SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 52 KG