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

Model Number	G52260
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = lab manager.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 a peripheral angioplasty within the distal superficial femoral artery, an advance 35 lp low profile balloon catheter ruptured longitudinally, below nominal pressure, upon the first inflation.An unspecified cook 6 french ansel sheath and cook sphere inflation device were used during the procedure.A 50/50 mixture of contrast was used to inflate the balloon.The balloon was removed by itself, without the sheath.Calcification was reported.Severity of the occlusion/lesion treated is unknown.The device was not inflated within a stent prior to rupturing.Another unknown balloon was used to successfully complete the procedure.During the same procedure, a cook advance 18 lp low profile balloon catheter ruptured and will be reported under patient identifier (b)(6).
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, unavailable, or unchanged.Initial report: as reported, during a peripheral angioplasty within the distal superficial femoral artery, an advance 35 lp low profile balloon catheter ruptured longitudinally, below nominal pressure, upon the first inflation.An unspecified cook 6 french ansel sheath and cook sphere inflation device were used during the procedure.A 50/50 mixture of contrast was used to inflate the balloon.The balloon was removed by itself, without the sheath.Calcification was reported.Severity of the occlusion/lesion treated is unknown.The device was not inflated within a stent prior to rupturing.Another unknown balloon was used to successfully complete the procedure.During the same procedure, a cook advance 18 lp low profile balloon catheter ruptured and will be reported under patient identifier (b)(6).Investigation ¿ evaluation.Reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, and a visual inspection and functional test of the returned device were conducted during the investigation.The device was returned with bio-matter throughout and both marker bands present.During an initial visual inspection, no damage was noted to the device.The device was inflated, and a pinhole was noted on the distal end of the balloon.Investigators were able to recreate the reported failure mode.Additionally, a document-based investigation evaluation was performed.A review of the device history record showed one nonconforming event which could potentially be related to this failure.However, the non-conforming device was identified and scrapped.It should also be noted there were no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the quality controls or inspection procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.An ifu is provided with this device which states, ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the available information and an inspection of the returned device, cook has concluded that a definitive conclusion could not be determined.A possible cause of the failure is the patient¿s calcified anatomy.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.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.

• 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: 9574670
• Report Number: 1820334-2020-00094
• Device Sequence Number: 2902099
• Product Code: DQY
• UDI-Device Identifier: 10827002522609
• UDI-Public: (01)10827002522609(17)220221(10)9540019
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/18/2020

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: 02/21/2022
• Device Model Number: G52260
• Device Catalogue Number: PTA5-35-135-5-8.0
• Device Lot Number: 9540019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1