MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO HF 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 Code	No Patient Involvement (2645)
Date of Event	10/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebr0189 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Per sales rep, the facility reported a deformity with micro-introducer tip.It was not used on patient, noticed prior to placement.
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 deformity on the introducer tip is confirmed, and the cause is determined to be manufacturing related.The device returned was one 5 fr microintroducer with dilator.Visual observation found the dilator to be fully attached to the sheath.No residue on the device was apparent.There was a large deformed area on the tip of the introducer sheath.Microscopic observation found that the introducer sheath tip was extremely deformed for about half its circumference.Splitting the sheath apart found that the wall of the sheath at the tip was pushed in proximally.The tipped portion of the sheath appeared irregularly shaped.However, the tip of the sheath where it was not deformed was not blunted.The complaint device was found during preliminary evaluation to be covered in use residues, suggesting it had been in contact with the patient, and the tip of the dilator manifested some abrasion at the inside of the tip, such as might be caused by traveling over a guidewire.A lot history review (lhr) of rebr0189 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Per sales rep, the facility reported a deformity with micro-introducer tip.It was not used on patient, noticed prior to placement.

• Brand Name: POWERPICC SOLO HF 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: 6993722
• Report Number: 3006260740-2017-01934
• Device Sequence Number: 16531101
• Product Code: LJS
• UDI-Device Identifier: 00801741132070
• UDI-Public: (01)00801741132070
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CK000291B
• Device Lot Number: REBR0189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1