MAUDE Adverse Event Report: COOK INC SPHERE INFLATION DEVICE

Catalog Number CID-20-30

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

Common name & product code = ptm syringe, balloon inflation, exempt; koe dilator, urethral.(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

As reported, during a percutaneous transluminal angioplasty procedure, a sphere inflation device manometer did not function.Another device was used to complete the procedure.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 Description

No new patient or event information to report.

Manufacturer Narrative

Description of event: investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, documentation, the instructions for use, manufacturing instructions, and quality control data.The complaint device was returned to cinc.There was no damage noted to the device in the initial check in at cinc.The device was then shipped to the supplier atrion for the device failure analysis to be completed.The complete supplier investigation is attached to the complaint file.The supplier could not confirm the complaint as manufacturing related because the gauge was discovered to exhibit crystallization and corrosion, the hose exhibited discoloration, and scuffing was observed on the threads of the plunger, which was all indicative of re-use of the device.The corrosion/crystallization was normally observed after a liquid, had been introduced to the device and allowed to evaporate.This corrosion/crystallization prevented the gauge from being responsive during original functional testing, and was believed to have broken loose from pressurization finally allowing the gauge to respond.The supplier's manufacturing process was a dry process, and there are no fluids introduced to the device at any point after assembly.Therefore, there are no assignable corrective actions to be taken at this time.Thank you for your feedback.This report concludes our investigation of the above listed complaints.The information generated or data accumulated will be filed for future reference, trends, or audits.We will continue to monitor and trend any problems associated with this device as we strive to continuously improve our products.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows one other complaint associated with the complaint device lot.The other complaint was from the same facility (pr308902), however the investigation determined that this complaint was not due to manufacturing issues.With this information in mind there is objective evidence to support that the device was manufactured to specification.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.While a definitive cause for this complaint could not be determined, the supplier investigation on the lot concluded that the lot was manufactured to specification.It was discovered that the gauge exhibited crystallization and corrosion indicate of re-use of the device.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

This report is being submitted as a correction.Upon further review, it has been determined that atrion is the labeled manufacturer of the complaint device and is therefore responsible for all regulatory reporting and complaint investigation requirements.The complaint information has been provided to the manufacturer (atrion) and entered in the complaint file by cook inc.

• Brand Name: SPHERE INFLATION DEVICE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10522499
• MDR Text Key: 207767604
• Report Number: 1820334-2020-01666
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 10827002310275
• UDI-Public: (01)10827002310275(17)220731(10)96271420
• Combination Product (y/n): N
• PMA/PMN Number: K953522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: CID-20-30
• Device Lot Number: 96271420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 01/29/2021; 05/03/2021
• Supplement Dates FDA Received: 02/04/2021; 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR