MAUDE Adverse Event Report: COOK INC TURBO-JECT® DOUBLE LUMEN BEDSIDE 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 Code Available (3191)
Type of Reportable Event	Serious Injury
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
Customer reported that a patient was undergoing placement of a turbo-ject® double lumen bedside power-injectable picc line for an unspecified indication.Vein access through the arm was made without complications using ultrasound with positive blood return to catheter with subsequent placement of an mst guidewire.A dilator was inserted over the wire and into the vein without compilation or resistance.Resistance was felt while attempting to remove the mst wire; repositioning of the arm did not reduce the resistance.The dilator was removed from the arm with the wire in place and no resistance was noted.The wire remained in the pt.'s arm and resistance was still present with attempt to remove.The patient was taken to interventional radiology for explant of the guide wire.No further adverse events were reported.No further event or patient details were provided.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, manufacturing instructions, specifications, instructions for use (ifu), quality control data, and visual inspection was conducted during the investigation.The product was returned for investigation in the used and damaged position.There is white adhesive tape on the mandrel portion of the wire very near to the proximal solder, and there is a small piece of a gauze-type dressing entangled in the unraveled coil.The coil is completely unraveled but remains soldered to the mandrel at the proximal junction.The mandrel is very short and appears to have been cut.The end weld is still present and attached to the distal tip of the unraveled coil but is no longer attached to the mandrel.Since the end weld bead remains connected to the distal tip of the unraveled wire, we can confirm that the entirety of the coil remains intact with no portion absent or separated.Neither the needle nor the dilator were returned for inspection; therefore, we cannot assess how either of those components may have contributed to the reported failure.A document-based investigation evaluation did not observe any specific issues with current manufacturing or quality controls.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.The reported failure could not be duplicated, although the unraveled coil was observed.It is possible, based on the provided information and evaluation of returned device that the root cause of this event is related to clinical technique or patient anatomy, however we do not have enough evidence to identify a definitive root cause at this time.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: TURBO-JECT® DOUBLE LUMEN BEDSIDE 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: 6682218
• Report Number: 1820334-2017-01483
• Device Sequence Number: 197836
• Product Code: LJS
• UDI-Device Identifier: 00827002237155
• UDI-Public: (01)00827002237155(17)180815(10)7200906
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K072625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2018

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 Model Number: N/A
• Device Catalogue Number: UPICDS-4.0-CT-40NT-1110
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/03/2017
• Supplement Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 01/22/2018
• 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