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

Model Number	G34359
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported, during a right superficial femoral artery balloon angioplasty procedure, the advance 35 lp low profile balloon catheter leaked.While inflating the device under x-ray guidance, contrast was noted to be leaking from the proximal section of the balloon.At that time, the balloon was withdrawn and removed from the procedure.There was no harm to the patient.A section of the device did not remain inside the patient¿s body.The patient did not require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 information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.
Event or Problem Description
Additional information was received 14jan2020.Another manufacturer's 5 or 6 french sheath was used during the procedure.An unknown inflation device was used to inflate the balloon, using a 50/50 solution of omnipaque, within the total occlusion of the superficial femoral artery/proximal popliteal artery.A slow leak was observed immediately upon the first inflation.The device was removed from the patient, by itself, and was then tested.Angulation and tortuosity were not reported; however, minor calcification was noted.
Additional Manufacturer Narrative
Additional information: 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.
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.Investigation ¿ evaluation.Reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, and a visual inspection & functional test of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one used pta5-35-80-5-20.0 device was received.There was no visible damage on the device; however, there appeared to be trace amounts of biomatter.The proximal balloon bond was noted to be within specification.Both marker bands were present and undamaged.There was also a pinhole leak at the proximal end of the balloon.A document-based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Reviews of the manufacturer¿s instructions, drawing, and quality control procedures were conducted, and no gaps were discovered.An ifu is provided with this device, which notes ¿store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ additionally, it goes on to note ¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit." a capa was previously completed to address the increasing trend of balloon rupture for pta4 and pta5 devices.The capa identified root causes related to inadequate manufacturing controls and implemented corrective actions to address the root causes.The complaint device was manufactured prior to the conclusion of capa implementation actions.Based on the condition of the returned complaint device, it cannot be confirmed that the inadequate manufacturing related controls identified as the root causes in the capa are related to this incident.Based on the information provided and the examination of the returned product, investigation has concluded that a root cause for this event could not be determined.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: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9152806
• Report Number: 1820334-2019-02529
• Device Sequence Number: 2941763
• Product Code: LIT
• UDI-Device Identifier: 10827002343594
• UDI-Public: (01)10827002343594(17)220716(10)9881875
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K132020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2020

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: 07/16/2022
• Device Model Number: G34359
• Device Catalogue Number: PTA5-35-80-5-20.0
• Device Lot Number: 9881875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 01/14/2020; 02/18/2020
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 02/13/2020; 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5 OR 6 FRENCH CORDIS SHEATH.