MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	G35532
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: (b)(6).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 angioplasty using an advance 35 lp low profile balloon catheter, the balloon leaked.The physician advanced the balloon catheter into position with no difficulties.Upon the initial inflation, the balloon leaked into the vessel and failed to hold pressure.There was no angulation, vessel tortuosity, or vessel calcification noted.The device was removed and another same type device was used to complete the procedure with no further complications.No device segment remained inside of the patient.No additional procedures were needed as a result of this occurrence.No adverse effects were reported as a result of this occurrence.
Event or Problem Description
Additional information received 20nov2020: the balloon was being advanced to the right distal sfa, an inflation device was used to inflated the balloon with a 50/50 solution of contrast and saline, when it was found that the device would not hold pressure.After removing the device the user inflated the balloon on the surgical table and noted that there was an apparent leak at the most proximal portion of the balloon.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, during an angioplasty using an advance 35 lp low profile balloon catheter, the balloon leaked.The physician advanced the balloon catheter to the right distal sfa with no difficulties.An inflation device was used to initially inflate the balloon with 50/50 contrast and saline when the balloon leaked into the vessel and failed to hold pressure.There was no angulation, vessel tortuosity, or vessel calcification noted.The device was removed and another same type device was used to complete the procedure with no further complications.Investigation ¿ evaluation.A document based investigation was performed including a review of complaint history, device history record, documentation, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.The complaint device was not returned; therefore, no physical examinations could be performed.A device retained by cook from the same product lot was evaluated.The balloon was inflated to the rated burst pressure of 15atm, and a leak was noted from a pinhole in the proximal end of the balloon.No issues were noted to the proximal bond.The cause of the pinhole leak in the representative device is unknown.Additionally, it is unknown if the failure of the complaint device and representative device from the same lot can be traced to the same cause.A review of the device history record found one potentially related non-conformance for surface defect on the balloon.The non-conforming product was scrapped and not replaced.A review of complaint history records shows no other complaints associated with the complaint device lot.There is no evidence of nonconforming devices from the complaint lot in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings: ¿do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.Over-inflation may cause rupture of the balloon, which resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.¿ ¿do not use a power injector for balloon inflation or injection of contrast medium through catheter lumen marked ¿distal¿.Rupture may occur.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded that a definitive conclusion could not be determined.As the complaint device and representative device experienced the same failure, the product lot was contained, as other units in the lot could potentially also be affected by this issue.It is unknown if the failure of the complaint device and representative device from the same lot can be traced to the same cause.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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
No new patient or event information to report.

• Brand Name: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10870296
• Report Number: 1820334-2020-02164
• Device Sequence Number: 2636081
• Product Code: LIT
• UDI-Device Identifier: 10827002355320
• UDI-Public: (01)10827002355320(17)230217(10)10332055
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2021

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: 02/17/2023
• Device Model Number: G35532
• Device Catalogue Number: PTA5-35-135-5-20.0
• Device Lot Number: 10332055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 11/20/2020; 03/22/2021
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 11/30/2020; 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1