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

Model Number	G52353
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: lead tech.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a thrombectomy procedure performed on the arm of a (b)(6) year-old male patient with a history of dialysis, a cook advance 35 lp low profile balloon catheter ruptured while in the patient.The balloon was used alongside another manufacturer's 5 fr or 6 fr sheath.Balloon inflation was attempted once, using a cook inflation device and a 50/50 optiray contrast solution, for less than one minute in the stenosed area; however the balloon was unable to be inflated past two atmospheres.The balloon was removed by itself and the rupture was then observed.The balloon remained attached to the shaft of the catheter at both ends; however, two holes, one at each end of the balloon, were observed.The procedure was subsequently completed with another cook 35 advance lp device.It is unknown if blood was observed in the inflation device.The balloon was not inflated inside a stent prior to rupture.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation/evaluation: reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturer¿s instructions, specifications, and quality control procedures, and a dimensional verification, functional test, and visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed a pinhole rupture of the balloon located 75.5cm from the strain relief.During attempted inflation, the balloon lost pressure and began to leak due to the pinhole.The catheter shaft and endhole were smooth and had no surface damage.Both marker bands were present.Blood was observed inside the balloon.The balloon catheter length was within specified tolerance.Additionally, 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 be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawing, specifications, and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with the device, which states ¿upon removal from package, inspect the catheter to ensure no damage has occurred during shipping.¿ it goes on to say ¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.¿ based on the information provided and the examination of the returned product, 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: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8883783
• Report Number: 1820334-2019-01986
• Device Sequence Number: 16734674
• Product Code: DQY
• UDI-Device Identifier: 10827002523538
• UDI-Public: (01)10827002523538(17)220625(10)9833988
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2019

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: 06/25/2022
• Device Model Number: G52353
• Device Catalogue Number: PTA5-35-80-7-6.0
• Device Lot Number: 9833988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 09/16/2019
• 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: TERUMO SHORT SHEATH, 5FR OR 6FR
• Patient Age: 67 YR