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

Model Number	G52268
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during an angiogram of the right lower extremity with possible intervention, an advance 35 lp low profile balloon catheter separated in the patient.The device was retrieved with a snare and the patient was transferred to another hospital.The patient was considered high risk, with many pre-existing conditions.During the same procedure, a cook flexor sheath also separated.That event will be reported under patient identifier (b)(6).According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Original reported device was a pta5-35-135-5-4.0.A photo of the package shows a pta5-35-135-6-10.0.Initial reporter occupation = administration officer.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.H1: it was initially reported that the device associated with this report separated.However, a photo provided by the customer of the complaint device did not show any type of separation of the balloon or balloon catheter material.When asked to clarify what part of the device separated, the customer responded that "the sheath separated", and reported that the balloon was successfully withdrawn from the sheath, indicating that the advance 35 lp low profile balloon catheter did not separate.Therefore, there is no alleged deficiency in identity, quality, durability, reliability, safety, effectiveness, or performance of the device associated with this report.Additionally use of the advance 35 lp low profile balloon catheter did not result ins a serious injury or death.The balloon used in this case has been reported as a concomitant device in report mdr #: 1820334-2021-02754.Therefore, the use of the advance 35 lp low profile balloon catheter is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury or reportable product malfunction report.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
Additional information was received.The balloon device was successfully withdrawn from the sheath associated with report with mdr #: 1820334-2021-02754.When asked if the balloon catheter or balloon material separated, the customer replied with "the sheath separated".Additionally, a photo provided by the customer does not show any separation of the balloon or balloon catheter material associated with this report.

• 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: 13118160
• Report Number: 1820334-2021-02753
• Device Sequence Number: 4562420
• Product Code: DQY
• UDI-Device Identifier: 10827002522685
• UDI-Public: (01)10827002522685(17)240709(10)14078841
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2022

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: 07/09/2024
• Device Model Number: G52268
• Device Catalogue Number: PTA5-35-135-5-4.0
• Device Lot Number: 14078841
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• 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: KCFW-8.0-38-70-RB-RAABE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 96 KG