MAUDE Adverse Event Report: COOK INC CODA LP BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number G03831

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported when the physician was preparing devices for the endovascular aneurysm repair (evar), an unidentified foreign matter was found in the package containing the coda lp balloon catheter.No adverse effects to the patient reported.

Manufacturer Narrative

Investigation ¿ evaluation.Initially it was reported that the device will be returned.However, notification from the dealer was received advising they inadvertently discarded the relevant device and therefore, it will not be returned to us.The device was not returned for an analysis and no photos were provided.Without the complaint device, a physical investigation was not able to be completed.A document based investigation has been performed which includes a review of complaint history, the device history record, the instructions for use, and quality control data.The device history record was reviewed and no related non-conformances were identified.A review of complaint history revealed this complaint to be the only reported complaint associated to the complaint lot number 8399876.Each zenith device is shipped with instructions for use (ifu, listing the indications for use, contraindications, warnings and precautions.The manufacturing documents in place at the time of manufacture were reviewed and it was found that the packaging was visually inspected by quality control and no notable gaps in production or processing controls were identified.Foreign matter is 100% checked for during manufacturing.No information was given by the customer as to whether the foreign matter was found before the package was opened or if the package was opened before discovery.No images of the foreign matter were given.Since it was stated that this foreign matter was sealed in the package, it must have been introduced during the manufacturing process.It was determined that no further risk reduction activities will be required at this time.The appropriate cook personnel have been notified of this event.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.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.Investigation ¿ evaluation.Initially it was reported that the device will be returned.However, notification from the dealer was received advising they inadvertently discarded the relevant device and therefore, it will not be returned to us.The device was not returned for an analysis and no photos were provided.Without the complaint device, a physical investigation was not able to be completed.A document based investigation has been performed which includes a review of complaint history, the device history record, the instructions for use, and quality control data.The device history record was reviewed and no related non-conformances were identified.A review of complaint history revealed this complaint to be the only reported complaint associated to the complaint lot number 8399876.Each zenith device is shipped with instructions for use (ifu, listing the indications for use, contraindications, warnings and precautions.The manufacturing documents in place at the time of manufacture were reviewed and it was found that the packaging was visually inspected by quality control and no notable gaps in production or processing controls were identified.Foreign matter is 100% checked for during manufacturing.No information was given by the customer as to whether the foreign matter was found before the package was opened or if the package was opened before discovery.No images of the foreign matter were given.Since it was stated that this foreign matter was sealed in the package, it must have been introduced during the manufacturing process.It was determined that no further risk reduction activities will be required at this time.The appropriate cook personnel have been notified of this event.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.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: CODA LP BALLOON CATHETER
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7324636
• MDR Text Key: 102196248
• Report Number: 1820334-2018-00510
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00827002038318
• UDI-Public: (01)00827002038318(17)201128(10)8399876
• Combination Product (y/n): N
• PMA/PMN Number: K032869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G03831
• Device Catalogue Number: CODA-2-9.0-35-120-32
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1