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

Model Number	G56201
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(b)(4).A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a port implantation procedure via jugular vein access, the tip of a micropuncture transitionless access set introducer separated in the patient.The 0.018-inch wire and insertion catheter were inserted without difficulty or resistance.The inner cannula was removed and another manufacturer's wire was inserted.As the user attempted to remove the outer cannula, it separated in the patient.Resistance was not reported and the anatomy was normal.The separated portion of the device was removed with a snare.Another device of the same type was used to complete the procedure.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 new patient or event information to report.
Additional Manufacturer Narrative
As reported, during a port implantation procedure via jugular vein access, the tip of a micropuncture transitionless access set introducer separated in the patient.The 0.018-inch wire and insertion catheter were inserted without difficulty or resistance.The inner cannula was removed and another manufacturer's wire was inserted.As the user attempted to remove the outer cannula, it separated in the patient.Resistance was not reported and the anatomy was normal.The separated portion of the device was removed with a snare.Another device of the same type was used to complete the procedure.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, quality control data, and specifications.One device was returned for investigation.The customer returned one separated mpis outer catheter.There was biological matter throughout.The catheter was separated into two sections.The proximal section included the hub and 2.5cm of tubing.The distal section of tubing measured 8.2cm.The separation sites on both sections were damaged, and appeared to have been cut.The distal tip was also damaged.An 8.4cm long section of the inner catheter was lodged inside the distal section of outer catheter.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 no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: this product is intended for use by physicians trained and experienced in diagnostic and interventional techniques.Standard techniques for placement of vascular access sheaths should be employed.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.Cook confirmed this complaint based on device evaluation.The returned device was separated and appeared to have been cut.The user stated that the device started separating when it was removed over the amplatz wire guide, but did not note resistance during insertion or removal.It is possible that the introducer became caught on the amplatz wire guide which led to separation, but this was not confirmed.There is no evidence of design or manufacturing deficiency, therefore, the cause of this event is component failure.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.

• Brand Name: MICROPUNCTURE TRANSITIONLESS ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10111245
• Report Number: 1820334-2020-01049
• Device Sequence Number: 19613569
• Product Code: DYB
• UDI-Device Identifier: 00827002562011
• UDI-Public: (01)00827002562011(17)221210(10)10202850
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K171275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2022
• Device Model Number: G56201
• Device Catalogue Number: MPIS-402-NT-U-SST
• Device Lot Number: 10202850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 07/28/2020
• 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: BOSTON SCIENTIFIC AMPLATZ WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR