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

Model Number	G52332
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the initial reporter, it is unknown if the device will be returned.Occupation = non-healthcare professional.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, prior to use during an unknown procedure, a pinhole leak was observed on an advance 35 lp low profile balloon catheter.The device did not make contact with the patient.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
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: d10, h3.The product was returned to cook.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, unchanged, or unavailable.Summary of event: as reported, prior to use during an unknown procedure, a pinhole leak was observed on an advance 35 lp low profile balloon catheter.The device did not make contact with the patient.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.Investigation evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection and functional test of the complaint device was conducted during the investigation.Inspection of the complaint device found that one prior-to-use advance 35 lp low profile balloon catheter was returned.The catheter and balloon did not appear damaged.A leak test was performed; however, the balloon would not inflate due to the presence of hardened contrast medium in the catheter.No leaks were found in the catheter shaft.No other issues were identified during the analysis.A document-based investigation evaluation was performed.One possibly-related non-conformance was found; however, affected units were scrapped and not replaced.There have been no other reported complaints for this lot number.As there are no lot-related complaints and non-conforming units were identified during manufacture and scrapped accordingly, there is objective evidence that the lot was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.The product ifu states: ¿the balloon is manufactured from an extra-thinwall, high-strength, minimally compliant material.Particular care should be taken in handling the balloon to prevent damage.It will inflate to the indicated size parameters when utilizing proper pressure recommendations.Adhere to balloon inflation pressure parameters indicated in the compliance card insert.Refer to label for further information.Use of a pressure gauge is recommended to monitor inflation pressures.¿ the ifu also instructs: ¿upon removal from package, inspect the catheter to ensure no damage has occurred during shipping.Prepare balloon lumen with standard contrast-saline mixture.¿ a review of the manufacturer¿s instructions and quality control procedures was conducted, and no gaps were discovered.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that it is most likely that the balloon was inadvertently damaged during either transport or storage.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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.

• 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: 9539346
• Report Number: 1820334-2020-00034
• Device Sequence Number: 19418276
• Product Code: DQY
• UDI-Device Identifier: 10827002523323
• UDI-Public: (01)10827002523323(17)220917(10)10016085
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2020

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: 09/17/2022
• Device Model Number: G52332
• Device Catalogue Number: PTA5-35-80-4-4.0
• Device Lot Number: 10016085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 02/20/2020; 05/07/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 04/15/2020; 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR