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

Catalog Number	PTA5-35-135-4-14.0
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E3: occupation: lead tech 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
It was reported that during an unknown procedure an advance 35 lp low profile balloon catheter's balloon ruptured while inflating due to heavy calcium and cto (chronic total occlusion).The user was able to take balloon off the wire and use a new unspecified balloon to complete the procedure.A section of the device did not remain inside the patient's body.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information has been requested.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5, d9, d10, 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.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
Additional information received 10apr2024.The intended procedure was a lower extremity angiogram.The lesion was located at the distal superficial femoral/popliteal artery and was 35% occluded.Another manufacture's 6 french sheath and unspecified inflation device were used during the procedure.The balloon was inflated to nominal pressure (10 atmospheres) once for 15 seconds.After the balloon ruptured, the balloon catheter and sheath were both removed over the wire.Blood was not noted in the inflation device and the balloon was not inflated inside of a stent prior to the rupture.
Additional Manufacturer Narrative
Correction: h6, annex a summary of event: it was reported that during an unknown procedure an advance 35 lp low profile balloon catheter's balloon ruptured while inflating due to heavy calcium and cto (chronic total occlusion).The user was able to take balloon off the wire and use a new unspecified balloon to complete the procedure.A section of the device did not remain inside the patient's body.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information received 10apr2024.The intended procedure was a lower extremity angiogram.The lesion was located at the distal superficial femoral/popliteal artery and was 35% occluded.Another manufacture's 6 french sheath and unspecified inflation device were used during the procedure.The balloon was inflated to nominal pressure (10 atmospheres) once for 15 seconds.After the balloon ruptured, the balloon catheter and sheath were both removed over the wire.Blood was not noted in the inflation device and the balloon was not inflated inside of a stent prior to the rupture.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), drawings, and quality control procedures were conducted during the investigation.A functional test and visual inspection were conducted as well.The complaint device was returned to cook for investigation.A pinhole was noted in the balloon.During a leak test, biomatter could be seen bubbling out of the balloon from a pinhole.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot.A review of complaint history found no additional complaints for this lot number.The product ifu states ¿under fluoroscopy, advance the balloon to the lesion site.Carefully position the balloon across the lesion using both the distal and proximal radiopaque balloon markers.Note: if resistance is met while advancing the balloon dilation catheter, determine the cause and proceed with caution.¿ a review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, returned product, and complaint file 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.Based on the information provided and the results of the investigation, cook has concluded that patient anatomy contributed to this incident.The user stated the patient¿s anatomy was heavily calcified and they were treating a cto lesion.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 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: 19005012
• Report Number: 1820334-2024-00440
• Device Sequence Number: 9438145
• Product Code: DQY
• UDI-Device Identifier: 10827002522562
• UDI-Public: (01)10827002522562(17)260803(10)CINC002564
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2024

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: 08/03/2026
• Device Catalogue Number: PTA5-35-135-4-14.0
• Device Lot Number: CINC002564
• 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: 03/08/2024
• Supplement Date Received by Manufacturer: 04/10/2024; 05/21/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 04/18/2024; 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2023
• 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: TERUMO 6 FRENCH SHEATH
• Patient Sex: Unknown