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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This investigation is currently under investigation.
Event or Problem Description
The physician numbed area to be accessed, made small nick with blade, inserted mpis needle into jugular vein.Next he inserted the mpis wire into the needle, then removed the needle.He then placed the sheath/dilator coaxial set over the wire into the vein, then removed both the inner dilator and wire together.Next he inserted the.035 j wire from the bard set through the access sheath.When he attempted to pull the access sheath out, the sheath snapped about 1/3 of the way distal from the hub, with 2/3 remaining inside the vessel.Physician then cut down the access site a little more, inserted an 8f sheath over the wire, and inserted a snare along side the wire through the same sheath.He then snared the end of the j wire, which had the mpis piece still over it, and removed everything at once.The case was able to be completed with the patient having the trialysis catheter successfully placed.Patient is fine.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The access site required further cut down and a snare was used to remove the broken portion of the device from the patient.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, dimensional verification, device history record,and visual inspection of the returned device was conducted during the investigation.The customer returned one used and damaged outer sheath from the mpis-401-sst complaint device.The sheath appears to be separated near the proximal end by the hub.The sheath appears to have blood/bio matter.The returned outer sheath was separated at 1.8 cm distal to the proximal hub.The customer also returned the separated segment, which measured 8.5 cm.There was some stretching observed at the point of separation.There was a bend in the separated segment of approximately 5 degrees.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the review of this information and the returned complaint device it is feasible to suggest that the device encountered high forces on the attempt to remove it.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
The physician numbed area to be accessed, made small nick with blade, inserted mpis needle into jugular vein.Next he inserted the mpis wire into the needle, then removed the needle.He then placed the sheath/dilator coaxial set over the wire into the vein, then removed both the inner dilator and wire together.Next he inserted the.035 j wire from the bard set through the access sheath.When he attempted to pull the access sheath out, the sheath snapped about 1/3 of the way distal from the hub, with 2/3 remaining inside the vessel.Physician then cut down the access site a little more, inserted an 8f sheath over the wire, and inserted a snare along side the wire through the same sheath.He then snared the end of the j wire, which had the mpis piece still over it, and removed everything at once.The case was able to be completed with the patient having the trialysis catheter successfully placed.Patient is fine.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The access site required further cut down and a snare was used to remove the broken portion of the device from the patient.

• 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: 5733331
• Report Number: 1820334-2016-00515
• Device Sequence Number: 19094744
• Product Code: DYB
• UDI-Device Identifier: 00827002479401
• UDI-Public: (01)00827002479401(17)190405(10)6868489
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2016

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MPIS-401-SST
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/25/2016
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2016
• Supplement Report FDA Received Date: 11/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 82