MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO HF CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 5F FUL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reds1194 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "rn inserted the picc line without any complications.This rn felt no resistance upon removing the stylet post insertion.Chest x-ray confirmed radiopaque stylet in catheter for tip confirmation.Also noted that about 5-6cm of stylet no longer in picc line.The stylet broke and was lodged in pulmonary artery.¿ additional information rcvd 06/04/2020 : the patient was prepped and drapped in the usual sterile fashion after surgical timeout was performed.Percutaneous access was gained to the left basilica vein with 21g introducer needle under ultrasound guidance.Using a modified seldinger technique a 0.46mm x 50cm guidewire was then inserted through the introducer needle allowing the needle to be removed.A microintroducer was inserted over the guidewire allowing the guidewire to be removed.After removing the vessel dilator, the picc was then inserted through the microintroducer into the selected vein.The peel-away sheath was then removed.Cr reveals tip in lower svc pending radiologist review.All ports flushed and aspirated easily.The picc was secured using the statlock device and sterile dressings were applied.The patient tolerated the procedure well and was returned to a position of comfort with the bed in low and locked position.Report given to a primary nurse.Patient response: patient tolerated procedure with no complaints.Additional information rcvd 06/05/2020 : the stylet wire appears to have broken off and lodged in the pulmonary artery as evidenced by the post picc insertion portable chest x-ray.
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken stylet is confirmed and was determined to be use related.One approximately 5 cm long segment of the distal end of a tls stylet was returned for evaluation.An initial visual observation showed the stylet segment was bent about 1 cm distal to its break site.A microscopic observation revealed the break site was somewhat stepped with a mostly flat surface.The proximal end of a magnet was observed to be protruding from the polyimide tubing at the break site.A break was observed in the fifteenth magnet from the distal end at the location of the observed bend.A second, smaller bend was observed in the stylet segment between the third and fourth magnets from the distal end.Plastic deformation was observed in the polyimide tubing at the break site as well as at the location of the bends in the stylet segment.The material deformation observed at the break in the stylet indicates the stylet was bent at this location to the point of breaking.This can occur if the distal end of the stylet extends past the distal end of the catheter during insertion, if the catheter is bent severely enough with the stylet still inserted, and/or if the stylet is manipulated within the catheter excessively and/or prior to flushing the catheter.A lot history review (lhr) of reds1194 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "rn inserted the picc line without any complications.This rn felt no resistance upon removing the stylet post insertion.Chest x-ray confirmed radiopaque stylet in catheter for tip confirmation.Also noted that about 5-6cm of stylet no longer in picc line.The stylet broke and was lodged in pulmonary artery.¿ additional information rcvd 06/04/2020 : the patient was prepped and draped in the usual sterile fashion after surgical timeout was performed.Percutaneous access was gained to the left basilica vein with 21g introducer needle under ultrasound guidance.Using a modified seldinger technique a 0.46mm x 50cm guidewire was then inserted through the introducer needle allowing the needle to be removed.A microintroducer was inserted over the guidewire allowing the guidewire to be removed.After removing the vessel dilator, the picc was then inserted through the microintroducer into the selected vein.The peel-away sheath was then removed.Cr reveals tip in lower svc pending radiologist review.All ports flushed and aspirated easily.The picc was secured using the statlock device and sterile dressings were applied.The patient tolerated the procedure well and was returned to a position of comfort with the bed in low and locked position.Report given to a primary nurse.Patient response: patient tolerated procedure with no complaints.Additional information rcvd 06/05/2020 : the stylet wire appears to have broken off and lodged in the pulmonary artery as evidenced by the post picc insertion portable chest x-ray.

• Brand Name: POWERPICC SOLO HF CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 5F FUL
• 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: 10192743
• Report Number: 3006260740-2020-02220
• Device Sequence Number: 908540
• Product Code: LJS
• UDI-Device Identifier: 00801741035890
• UDI-Public: (01)00801741035890
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• 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): 08/19/2020

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 Expiration Date: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 9395108Q
• Device Lot Number: REDS1194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 08/19/2020
• 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: Disability
• Patient Age: 55 YR