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

Model Number	PTA5-35-135-3-6.0
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2019
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 the advance 35 lp low profile balloon catheter leaked during an unspecified angioplasty procedure involving a (b)(6) year-old female patient with a history of "arterial peripheral disease." the balloon was properly introduced, with the distal tip reaching the injury site without complication.Reportedly, the lesion being treated was a non-occlusive stenosis with moderate calcification.As the physician began inflating the complaint device, the pressure on of the insufflator would not "hold", and slowly decreased.When the physician withdrew the device from the patient, the balloon was leaking form the proximal end, near the connection point between the balloon material and the shaft.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.
Event or Problem Description
Additional information was received on 16jul2019 noting that the target lesion was the posterior tibial artery.Additionally, there was no blood noted in the inflation device.
Additional Manufacturer Narrative
Additional information: 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
B5: additional information was received 01aug2019 stating that an unknown manufacturer's 6 french short introducer sheath was used during the procedure, and an unknown inflation device was used.The balloon was removed alone before procedure completion with another device.No further information regarding the patient and/or event has been received since the previous medwatch report was sent.Investigation/evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and no product returned, investigation has concluded that no cause could be established for the device failure.Measures are being conducted to address this failure mode.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: 8796727
• Report Number: 1820334-2019-01710
• Device Sequence Number: 1978113
• Product Code: LIT
• UDI-Device Identifier: 10827002343754
• UDI-Public: (01)10827002343754(17)210122(10)8525861
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K132020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2019

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: 01/22/2021
• Device Model Number: PTA5-35-135-3-6.0
• Device Catalogue Number: PTA5-35-135-3-6.0
• Device Lot Number: 8525861
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 07/29/2019; 08/01/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 08/01/2019; 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR