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Catalog Number RV135610
Device Problems Material Rupture (1546); Implant Mobility NOS (Not otherwise specified) (2645); Component or Accessory Incompatibility (2897); Device Markings/Labelling Problem (2911); Measurement System Incompatibility (2982)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/28/2014
Event Type  malfunction  
Manufacturer Narrative
The lot number for the device has been provided. A review of the device history records is currently being performed. The device has been returned to the manufacturer for evaluation. The investigation is currently underway. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complaint/reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Manufacturer Narrative
To ensure compliance to 21 cfr 803. 50 a retrospective review of this file was conducted to determine if good faith efforts were made to obtain the required information and/or an explanation of why any required information was not provided. Multiple follow up attempts were made with the facility to obtain any information pertaining to the patient, product, and/or procedural details (e. G. Date of the event, relevant test data, relevant history, lot #, catalog #, implant and/or explanted dates, and concomitant product(s) or therapy) that were not previously obtained during the initial investigation. The facility was able to provide new patient information, which was updated in the appropriate sections.
Manufacturer Narrative
The device history records have been reviewed with special attention to the raw materials, subassemblies, mfg process and quality control testing. This lot met all release criteria. The device was returned and three photos were provided for review. The device was returned. The balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 6mm x 10cm balloon. The compliance card for a 7mm rival balloon was attached to the packaging hoop. The patency of the guidewire lumen was then tested using an in-house 0. 035" guidewire and it passed without issue. The inflation hub was connected to an infection device, and an attempt was made to inflate the balloon with water. Upon inflation, a stream of water was seen exiting the balloon 7. 5cm from the distal tip. The location was examined under microscopic magnification (10x) and a pinhole rupture was observed approx 7. 5cm from the distal tip. The balloon could not be inflated to rbp due to the pinhole rupture, therefore, the diameter of the balloon could not be measured. The investigation is confirmed for a pinhole balloon rupture and a mislabeling issue where there was a compliance card mix-up. Per the reported event details, the balloon ruptured at 14atm and the compliance card included with the device was for a 7mm balloon that listed an rbp of 14atm. The rbp for product catalog# rv135610 is 12atm. Therefore, it is likely that the compliance card mix-up contributed to the user over pressurizing and rupturing the balloon, but the exact not cause for the burst is unk. Based upon the available info, the definitive root cause for the compliance card mix-up is unk. Additional investigation activities: the label history record (lhr) for the complaint lot (b)(4)) was reviewed. The compliance card is considered labeling and as such there are retains of the compliance card with every lhr. The compliance cards retained for the subject lot were correct. A review of the packaging logs revealed that a 7mmx4cm rival balloon catheter had been packaged on (b)(6) 2014. However, there were two other lots, a 5mmx2cm and an 8mmx4cm, packaged in between the 7mmx4cm and the 6mmx10cm lots. All 6mm and 7mm compliance cards, on the production floor, were sorted. No issues were found. The incoming inspection packet for the lot of 6mm compliance cards used on the complaint lot was reviewed. A sample size of 50 cards out of 4000 was proofread for correct print. There were no discrepancies. Purchasing contacted the supplier of the compliance cards, run systems, to review the lot documentation for the 6mm and 7mm compliance cards that may have been run in the same time frame. The supplier's response indicates that there was a 7mm compliance card job run on (b)(6) 2014 (shipped on 04/15/2014) and a 6mm compliance card job run on (b)(6) 2014 and shipped on 04/24/2014. There were 9 days between the production run and 200+ jobs run in between. The above mentioned activities have ruled out the potential mixing of the compliance cards at the supplier and at (b)(4). Field assurance ran a sales report, which shows that the account from which the complaint received, purchases both rival 6mm and 7mm product. While it cannot be confirmed, there is the potential that compliance card(s) were mixed at the complaint facility.
Event Description
It was reported that the pta balloon ruptured at the rated bust pressure (rbp) of 14atm during the first inflation in the sfa. The compliance card provided with the device indicates that the balloon was a 7mm and lists the rbp as 14atm; however, the outer box label and the device hub indicated the balloon was a 6mm x 10cm. Another balloon was used to complete the procedure. There was no reported patient injury.
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Manufacturer (Section D)
1625 west 3rd st.
tempe AZ 85281
Manufacturer (Section G)
289 bay road
queensbury NY 12804 2045
Manufacturer Contact
judith ludwig
1625 west 3rd st.
tempe, AZ 85281
MDR Report Key4731209
MDR Text Key13231402
Report Number2020394-2015-00523
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative,company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/30/2014
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2016
Device Catalogue NumberRV135610
Device Lot NumberGFYG3726
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/04/2014
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial