MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 9.5F DUAL-LUMEN CV CATHETER PEEL-APART INTRODUCER WITH SURECUFF TISSUE; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2016
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 reat0266 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by physician at the facility that the picc had a hole that was found during flushing as part of protocol after implantation; it was removed and replaced.No patient harm.
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 following were reviewed as part of this investigation: patient severity, trend 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 leaking chronic catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 9.5fr d/l groshong chronic catheter.The sample terminated 8.8 cm distal of the tissue ingrowth cuff.Microscopic inspection of the distal end of the sample revealed glossy striations typical of a sharp instrument cut.Usage residues were observed throughout the sample.Partially circumferential splits were observed in both extension tubes just proximal of the bifurcation.An attempt to infuse water through the sample using a 12 ml syringe revealed both lumens to be patent to infusion; however, leaks were observed emanating from both aforementioned splits.Tactile inspection of the sample revealed severe tensile weakness in the vicinities of both splits.Microscopic inspection of the two partial splits revealed sharply defined granular split edges.The split in the white-striped tubing was larger than that in the red-striped tubing.Material wear and buckling was observed in the vicinities of both splits.The split surfaces exhibited beach marks.The fracture features were consistent with material fatigue failure, wherein damage accumulates over time due to repetitive stress.The severe tensile weakness indicated that tensile (pulling) stress contributed to the observed damage.Care should be taken when securing, accessing and maintaining catheters to avoid damage.Tensile damage can occur during the tunneling procedure.The ifu provides the following warning pertaining to tunneling: ¿caution: the catheter must not be forced.¿.

• Brand Name: GROSHONG 9.5F DUAL-LUMEN CV CATHETER PEEL-APART INTRODUCER WITH SURECUFF TISSUE
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6261277
• Report Number: 3006260740-2016-00737
• Device Sequence Number: 921415
• Product Code: FOZ
• UDI-Device Identifier: 00801741041587
• UDI-Public: (01)00801741041587(17)210528(10)REAT0266
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K860256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2016

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 Expiration Date: 05/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 7726954
• Device Lot Number: REAT0266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/18/2017
• Supplement Report FDA Received Date: 03/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1