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

Model Number	G52293
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter occupation = non-healthcare professional.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 in-stent restenosis case involving the iliac vein, an advance 35 lp low profile balloon catheter ruptured and separated.An unknown sheath and inflation device were used in the case and isovue contrast was used to inflate the balloon.Calcification was not reported; however, the stenosed area was reportedly 100% occluded.The device was inflated to eight atmospheres at which time it ruptured circumferentially.An unknown wire guide was in the lumen of the device at the time of removal.The physician was able to remove the majority of the device; however, one of the distal markers is believed to have embolized in the lung.The decision was made to leave the marker in place, as the patient was stable.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, unchanged, or unavailable.Summary of event: as reported, during an in-stent restenosis case involving the iliac vein, an advance 35 lp low profile balloon catheter ruptured and separated.An unknown sheath and inflation device were used in the case and isovue contrast was used to inflate the balloon.Calcification was not reported; however, the stenosed area was reportedly 100% occluded.The device was inflated to eight atmospheres at which time it ruptured circumferentially.An unknown wire guide was in the lumen of the device at the time of removal.The physician was able to remove the majority of the device; however, one of the distal markers is believed to have embolized in the lung.The decision was made to leave the marker in place, as the patient was stable.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.Investigation evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications was conducted during the investigation.The complaint device was not returned for investigation; therefore, a visual inspection of the device was not possible.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 information provided upon review of complaint file, device history record, complaint history, and device master record, provide objective evidence to support that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The product ifu states: ¿the advance 35lp low profile pta balloon dilatation catheter is indicated for percutaneous transluminal angioplasty (pta) of lesions peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral, and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.¿ the ifu cautions the user: ¿the catheter is not intended for the delivery of stents.All stents should be deployed in accordance with the manufacturer¿s indications and instructions for use.¿ the ifu also instructs: ¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.¿ based on the information provided and the results of the investigation, cook has concluded that unintended use error and the procedure contributed to this incident.As reported, the procedure involved in-stent restenosis of the iliac vein.The product ifu precautions state ¿the catheter is not intended for the delivery of stents.¿ the risk analysis for this failure mode was reviewed and no action 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.

• 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
• MDR Report Key: 9539269
• Report Number: 1820334-2020-00033
• Device Sequence Number: 2340878
• Product Code: DQY
• UDI-Device Identifier: 10827002522937
• UDI-Public: (01)10827002522937(17)201115(10)8375068
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2020

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: 11/15/2020
• Device Model Number: G52293
• Device Catalogue Number: PTA5-35-135-10-4.0
• Device Lot Number: 8375068
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 06/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other