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

Catalog Number	MPIS-401-PED-NT-U-SST
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/06/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that during an angioplasty of the pulmonary valve, the micropuncture transitionless pediatric access set sheath was found to be split into two pieces.This event occurred at some point during cannulation of the femoral vein and was discovered when the sheath was removed.Only the proximal portion was extricated over another manufacturer's wire.The distal portion of the sheath was seen lodged in the femoral vein.The groin area had scarring from a previous cut down procedure but reportedly, this did not make the insertion of the sheath difficult.The complainant postulated the sheath must have split while in the patient; therefore, it could not have been cut since the wire was wholly intact upon removal.The complainant reported, the separated portion of the sheath was surgically removed and the patient is doing well.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.A review of the dimensional verification, complaint history, device history record, documentation, drawing, quality control, specifications, and a visual inspection of the returned devices were conducted during the investigation.Additionally, a photographic evaluation of an x-ray image of the patient¿s left groin was performed.Both used and unopened samples were returned for physical testing.A visual inspection of the complaint device confirmed that the outer sheath was separated a distance of 3.6 cm from proximal hub.The separated distal segment was approximately 6.8 cm long, and had a 45 degree bend beginning at a distance of 1.7 cm from the separation.There were multiple kinks and creases along the length of the separated distal segment.The inspection of the remaining unopened devices confirmed that all additional samples were within the established specifications for the product.The inspection of the returned photograph confirmed that the imaging was consistent with, but could not confirm, the complaint; this is because the fractured end of the catheter was not identifiable on the provided image.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed the lot was released meeting all finished goods release criteria.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, the root cause was determined to be related to a device component issue.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the 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.Refer to section h10 for investigation findings.

• Brand Name: MICROPUNCTURE TRANSITIONLESS PEDIATRIC ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7451365
• Report Number: 1820334-2018-01129
• Device Sequence Number: 1051914
• Product Code: DYB
• UDI-Device Identifier: 00827002479470
• UDI-Public: (01)00827002479470(17)191021(10)7377891
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 08/17/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MPIS-401-PED-NT-U-SST
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 08/17/2018
• 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: TERUMO WIRE; TERUMO WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 YR
• Patient Weight: 17