MAUDE Adverse Event Report: COOK INC TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
International customer reported that a patient underwent placement of a turbo-ject® double lumen power-injectable picc for an unspecified indication.The guide wire was damaged during removal, reported as "elongation (destruction)" following placement of the catheter.The procedure was completed without any further issues.There are no reported adverse patient consequences.The device was received by the manufacturer for evaluation.
Additional Manufacturer Narrative
Investigation - evaluation : a review of the drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control and visual inspection of the returned device was conducted during the investigation.The complaint device was returned and analyzed.Device was received with biomatter present.The coil was unraveled from the tip to the proximal solder joint.The mandril diameter, coil wire diameter, and coil outer diameter were measured with calipers and found to be in specification.The proximal solder joint was inspected under a microscope and it was confirmed that at least 3 coils were covered in solder.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 information provided, examination of the returned device and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.

• Brand Name: TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC
• Common Device Name: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6547010
• Report Number: 1820334-2017-00934
• Device Sequence Number: 18865517
• Product Code: LJS
• UDI-Device Identifier: 00827002239029
• UDI-Public: (01)00827002239029(17)180916(10)7273656
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K132885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2017

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UPICDS-5.0-CT-NT-1111
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2017
• Supplement Report FDA Received Date: 06/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1