MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided by bd represents all of the known information at this time.The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that a dual lumen powerpicc solo insertion was attempted on (b)(6) 2018, unsuccessful with multiple attempts.It was stated that rn was able to cannulate but was not placed in svc-aborted.Then a second clinician attempted with a single lumen, and unsuccessful.The patient came back to the hospital (monday (b)(6) 2018) with complaints of swelling and pain in right arm.Then patient was admitted after assessments and tests it was noted a 2.6 cm segment of wire in right subclavian vein.This report addresses the second catheter.Additional information received stated, "we were unable to advance the catheter past the level of the right subclavian.Resistance to the catheter was noted by both practitioners at the same point (the level of the right subclavian).No attempts were made to advance the catheter or the wire beyond that.Contralateral attempt not possible due to radical mastectomy with lymph node resection.".
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a break in the 3cg stylet was confirmed.The distal end of a 3cg stylet was returned for investigation.The stylet segment, which consisted of the polyimide tubing, conductive epoxy, magnets, and core wire, was 2.3cm in length.The proximal segment of the stylet was not returned for investigation.The polyimide tubing was kinked 5mm from the distal tip, which coincided with the proximal end of the conductive epoxy.What appeared to be biological residue (e.G.Blood) was visible throughout the sample.The broken end of the polyimide tubing was noted to be uneven.The wall thickness of the polyimide tubing was within specification.It was reported that multiple attempts were made to insert the catheter and resistance was reported at the right subclavian.While the exact cause of the reported event could not be determined from the returned sample.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that a dual lumen powerpicc solo insertion was attempted on (b)(6) 2018, unsuccessful w/ multiple attempts.It was stated that rn was able to cannulate but was not placed in svc- aborted.Then a second clinician attempted with a single lumen, and unsuccessful.The patient came back to the hospital (monday (b)(6) 2018) with complaints of swelling and pain in right arm.Then patient was admitted after assessments and tests it was noted a 2.6 cm segment of wire in right subclavian vein.This report addresses the second catheter.Additional information received stated, "we were unable to advance the catheter past the level of the right subclavian.Resistance to the catheter was noted by both practitioners at the same point (the level of the right subclavian).No attempts were made to advance the catheter or the wire beyond that.Contralateral attempt not possible due to radical mastectomy with lymph node resection.".

• Brand Name: POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8189573
• Report Number: 3006260740-2018-03684
• Device Sequence Number: 19360877
• Product Code: LJS
• UDI-Device Identifier: 00801741124068
• UDI-Public: (01)00801741124068
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2019

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 Model Number: N/A
• Device Catalogue Number: CK000524A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 02/13/2019
• 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: Other