MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET; DYB INTRODUCER, CATHETER

Model Number	G48002
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number = pre-amendment.This report includes information known at this time.A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.
Event or Problem Description
It was reported, the dilator from a micropuncture transitionless stiffened cannula access set would not lock into the introducer during an angiography.No patient adverse event occurred.This is a non-reportable event.The customer returned the complaint device along with an additional seven unopened/unused devices from the same lot.During preliminary visual inspection on 17may2019, a hole/split was found on the outer catheter at the distal tip of one of the returned devices.This report is being submitted for this unused micropuncture transitionless stiffened cannula access set.
Additional Manufacturer Narrative
Investigation ¿ evaluation: reviews of the complaint history, device history record, drawing, manufacturer¿s instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one mpis-401-10.0-sc-sst was returned for investigation under pr (b)(4).Upon examination of the unused device, a hole in the material at the tip of the outer coaxial catheter was noted.Additionally, a document based investigation evaluation was performed.There is evidence to suggest the product was not made to specifications as the failure was noted on an unused device.A review of the device history record showed no nonconforming events which could contribute to this failure mode.However, during the review of the device subassembly lot, there was a nonconformance noted which could potentially be related to the reported failure.However, the affected unit was scrapped and not replaced.It should also be noted that this lot did contain four other complaints, but none of the other complaints have the same failure mode.Furthermore, reviews of the manufacturer¿s instructions, drawing, specification and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and the examination of the returned product, investigation has concluded that this event can be traced to manufacturing and quality control.Given that this failure occurred on an unused, sealed device, it is likely that this device was not manufactured to specification.Retraining of the manufacturing and quality control operators has been requested, however the qc operators that processed these devices are no longer employed by cook and therefore cannot be retrained.Retraining for the manufacturing operators has been completed with the form attached to the complaint file.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8636716
• Report Number: 1820334-2019-01283
• Device Sequence Number: 1822296
• Product Code: DYB
• UDI-Device Identifier: 00827002480025
• UDI-Public: (01)00827002480025(17)220129(10)9483997
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2019

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: Other
• Device Expiration Date: 01/29/2022
• Device Model Number: G48002
• Device Catalogue Number: MPIS-401-10.0-SC-SST
• Device Lot Number: 9483997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1