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

Model Number	G52265
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a procedure involving treatment of a lesion within the superficial femoral artery, an advance 35 lp low profile balloon catheter's balloon ruptured.A cook sheath was used during the procedure.An unspecified inflation device was used to inflate the balloon one time to nominal pressure, for thirty seconds; however, the balloon ruptured longitudinally.The anatomy was calcified, and the lesion was 100% occluded.Blood was noted within the inflation device.The balloon was not inflated within a stent.The balloon catheter was pulled back into the sheath, over the wire guide, and removed.The procedure was completed successfully with a different balloon.During the same procedure, another cook balloon ruptured.That event will be reported under patient identifier (b)(6).A section of the device did not remain inside the patient¿s body.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Summary of event: as reported, during a procedure involving treatment of a lesion within the superficial femoral artery, an advance 35 lp low profile balloon catheter's balloon ruptured.A cook sheath was used during the procedure.An unspecified inflation device was used to inflate the balloon one time to nominal pressure, for thirty seconds; however, the balloon ruptured longitudinally.The anatomy was calcified, and the lesion was 100% occluded.Blood was noted within the inflation device.The balloon was not inflated within a stent.The balloon catheter was pulled back into the sheath, over the wire guide, and removed.The procedure was completed successfully with a different balloon.During the same procedure, another cook balloon ruptured.That event was reported under patient identifier 424870_mm.A section of the device did not remain inside the patient¿s body.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: reviews of the complaint history, device history record (dhr), drawing, instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection and functional test of the complaint device was also conducted.The complaint device was returned to cook for investigation.The middle of the balloon leaked during leak testing.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 relevant complaints for this lot number.The customer followed relevant instructions in the ifu (instructions for use).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, 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.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s anatomy contributed to this event.The anatomy was calcified, the lesion was 100% occluded, and another cook balloon also ruptured during the same procedure (reported under patient identifier 424870_mm).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: 19097496
• Report Number: 1820334-2024-00510
• Device Sequence Number: 12689117
• Product Code: DQY
• UDI-Device Identifier: 10827002522654
• UDI-Public: (01)10827002522654(17)270111(10)CINC005731
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2024

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 Model Number: G52265
• Device Catalogue Number: PTA5-35-135-6-4.0
• Device Lot Number: CINC005731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 04/17/2024; 07/08/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 04/24/2024; 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2024
• 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: ABBOTT SPARTACORE 1005303.; ANGIO-SEAL VIP 610130.; BOSTON 6F SHEATH.; COOK 6FR FLEXOR HIGH FLEX ANSEL 0.; COOK BSDN-18-7.0.; COOK HNBR5.0-38-65-P-NS-RIM.; COOK KCFW-6.0-18/38-45-RB-ANL0-HC.; COOK PTA5-35-135-5-8.0 LOT CINC001764.; GLIDECATH CG432.; LAKE REGION ZIP WIRE M00146317B0.; STEALTH 360 PERIPHERAL OAS PRD-SC30-150.; VOLCANO VISIONS PV 0.014P IVUS CATHETER 014R.
• Patient Age: 79 YR
• Patient Sex: Female